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The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos Digital Impression System (DIS) is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos DIS is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners. The Lythos DIS is a point-of-care turnkey imaging system used in the dental industry; the intra-oral wand hardware and personal computer (PC) based software form an integrated system that produces accurate, high resolution three dimensional (3D) digital images. The end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand along the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic or restorative appliance manufacturers to design and manufacture customized appliances. The Lythos DIS device is also equipped with wireless network capability for secure transfer of the 3D image data to the orthodontic or restorative appliance manufacturer. The Lythos DIS is only used to gather the topography of the mouth and teeth, and to upload the data file (.stl) to the data cloud. The data is available to the licensed dental professional to send to a third party manufacturer. The Lythos DIS .stl data file is used in conjunction with CAD/CAM or 3D printing manufacturing processes. The proposed Lythos DIS is not used for the design, diagnosis or treatment planning of orthodontic aligners.

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.

The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.

The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.

Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.

The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.

The Transitional Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors.

The Temporary Tooth Replacement is comprised of dental implant screws and prosthetic components. The system is designed to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. The system will consist of a screw and a molded pontic tooth that would be secured to the head of the screw using adhesive. The implant screw is removed once the patient reaches maturity and a permanent implant can be placed.

The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.

The device is a ceramic orthodontic bracket which will encompass maxillary and mandibular brackets from 2nd bicuspid to 2m bicuspid. The Damon 4Clear appliance has both aesthetic and self-ligating qualities. The Damon 4Clear is designed with 1) improved open and close functionality and increased corner radius for increased patient comfort, 2) enhanced bracket placement with placement jigs and 3) improved overall bracket performance without changing treatment mechanics, with rotation and torque control similar to other Damon metal brackets. This system is a bondable device for fixed attached orthodontics.

The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.

The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion). Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability. The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.